Abbreviated or Standard Dual Antiplatelet Therapy by Sex in Patients at High Bleeding Risk
Authors: Antonio Landi, Mirvat Alasnag, Dik Heg, Enrico Frigoli, Fazila Tun Nesa Malik, Ivan Gomez-Blazquez, Suzanne Pourbaix, Alaide Chieffo, Christian Spaulding, Fermin Sainz, Helen Routledge, Giuseppe Andò, Luca Testa, Alessandro Sciahbasi, Hussain Contractor, Nigel Jepson, Juan Mieres, Syed Saqib Imran, Husam Noor, Pieter C. Smits, Marco Valgimigli, Marco Valgimigli, Peter C. Smits, G.A. Van Es, G.B.W.E. Vos, E. Spitzer, Pascal Vrancks, Bernard Chevalier, Yukio Ozaki, Marie-Claude Morice, Stephan Windecker,  Yoshinobu Onuma, Enrico Frigoli, Andrè Frenk, Peter C. Jüni, Jan Tijssen, D. Paunovic, Mullasari S. Ajit, Mirvat Alasnag, Jozef Bartunek, Antonio Colombo, David Hildick-Smith, Andrés Iñiguez, Felix Mahfoud, Ran Kornowski, Maciej Lesiak, Paul J.L. Ong, Alfredo E. Rodriguez, Marco Roffi, Carl Schultz, Goran Stankovic, Pim Tonino, Aris Moschovitis, Peep Laanmets, Michael Donahue, M. Bertrand, Stuart Pocock, Philip Urban, Sergio Leonardi, Claude Hanet, Renato Lopes, Eùgene P. McFadden, Peter Radke, Risto O. Roine, Boudijn Ladan, Laura van der Waal, Yvonne Engelbrecht, Fred Paddenburg, Ben Ren, Ingrid de Zwart, Liliane Elshout, Judith Jonk, Tessa Rademaker-Havinga, Ria van Vliet, Phani Krishna Kondamudi, Laure Morsiani, Ute Windhövel, Anita van der Wal, Chantal Bakker, Kazuhiro Minagawa, Juan Mieres, Fernando Cura, Carlos Fernandez-Pereira, Astin Lee, Nigel Jepson, Robert Whitbourn, Owen Christopher Raffel, Kurt Huber, Franz Weidinger, Fazila-Tun-Nesa Malik Hasselt, Jessa Ziekenhuis, Imelda Ziekenhuis, Willem Dewilde, Adel Aminian, Emanuele Aalst, Suzanne Pourbaix, Panagiotis Xaplanteris, Vasil Velchev, Dimitar Karageorgiev, Hristo Mateev, Valeri Gelev, Petr Kala, Martin Mates, Henning Kelbæk, Thomas Hovasse, Laurent Delorme, Thomas Cuisset, Loïc Belle, Farzin Beygui, Christophe Piot, Jean François Morelle, Rene Koning, Mathieu Valla, Philippe Brunel, Guillaume Cayla, Emmanuel Teiger, Gilles Montalescot, Christian Spaulding, Phillipe Guyon, Pyxaras Stylianos, Bela Merkely, Imre Ungi, Rajpal K Abhaichand, Atul Damodar Abhyankar, Gunasekaran Sengottuvelu, Halabi Majdi, Ariel Roguin, Yair Feld, Chaim Lotan, Stefano Garducci, Bernhard Reimers, Gennaro Sardella, Antonio Milan, Alaide Chieffo, Corrado Tamburino, Giuseppe Andò, Luca Testa, Maurizio Di Biasi, Alessandro Sciahbasi, Paolo Calabro, Gianluigi Minervini, Bruno Loi, Franco Fabbiocchi, Jacopo Oreglia, Paolo Sganzerla, Kenji Ando, Yoshiharu Higuchi, Mamoru Nanasato, Yuki Ishibashi, Hitoshi Matsuo, Ruka Yoshida, Kiyokazu Shimizu, Haruo Kamiya, Nobuyuki Komiyama, Tetsuya Amano, Toyoaki Murohara, Seiji Yamazaki, Husam Noor, Sasko Kedev, Jakub Podolec, Krzysztof Reszuch, Adrian Wlodarczak, Dariusz Dudek, Pedro Canas da Silva, Ljupco Mangovski, Dragan Topic, Dragan Debeijacki, Paul Ong Jau Lueng, Syed Saqib Imran, Park Seung-Jung, Jose Francisco Diaz Fernandez, Brudo Garcia Del Blanco, Vicente Mainar, Iván Gómez-Blázquez, Eduardo Pinar, Javier Escaned Barbosa, Joan Antoni, Fermin Sainz, Javier Goicolea, Ole Fröbert, Robert Kastberg, Gregor Leibundgut, Giovanni Pedrazzini, Ali Garachemani, Patrick Siegrist, Stephane Cook, Al Mafragi, Gillian Aj Jessurun, Willem Theodoor Ruifrok, Peter Danse, Jawed Polad, Floris Kauer, Clemens von Birgelen, Jurrien Ten Berg, Sander Ijsselmuiden, Samer Somi, Tom Johnson, Helen Routledge, Jehangir Din, Shahzad Munir, John McDonald, Neville Kikreja, Mamas Mamas, Rajiv Das, Hussain Contractor, Aaron Peace, Rupert Williams, Nguyen Ngoc Quang
Journal: JAMA Cardiology (2023)

Importance Abbreviated dual antiplatelet therapy (DAPT) reduces bleeding with no increase in ischemic events in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI). Objectives To evaluate the association of sex with the comparative effectiveness of abbreviated vs standard DAPT in patients with HBR. Design, Setting, and Patients This prespecified subgroup comparative effectiveness analysis followed the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated vs Standard DAPT Regimen (MASTER DAPT) trial, a multicenter, randomized, open-label clinical trial conducted at 140 sites in 30 countries and performed from February 28, 2017, to December 5, 2019. A total of 4579 patients with HBR were randomized at 1 month after PCI to abbreviated or standard DAPT. Data were analyzed from July 1 to October 31, 2022. Interventions Abbreviated (immediate DAPT discontinuation, followed by single APT for ≥6 months) or standard (DAPT for ≥2 additional months, followed by single APT for 11 months) treatment groups. Main Outcomes and Measures One-year net adverse clinical events (NACEs) (a composite of death due to any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (MACCEs) (a composite of death due to any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding (MCB). Results Of the 4579 patients included in the analysis, 1408 (30.7%) were women and 3171 (69.3%) were men (mean [SD] age, 76.0 [8.7] years). Ischemic and bleeding events were similar between sexes. Abbreviated DAPT was associated with comparable NACE rates in men (hazard ratio [HR], 0.97 [95% CI, 0.75-1.24]) and women (HR, 0.87 [95% CI, 0.60-1.26]; P = .65 for interaction). There was evidence of heterogeneity of treatment effect by sex for MACCEs, with a trend toward benefit in women (HR, 0.68 [95% CI, 0.44-1.05]) but not in men (HR, 1.17 [95% CI, 0.88-1.55]; P = .04 for interaction). There was no significant interaction for MCB across sex, although the benefit with abbreviated DAPT was relatively greater in men (HR, 0.65 [95% CI, 0.50-0.84]) than in women (HR, 0.77 [95% CI, 0.53-1.12]; P = .46 for interaction). Results remained consistent in patients with acute coronary syndrome and/or complex PCI. Conclusions and Relevance These findings suggest that women with HBR did not experience higher rates of ischemic or bleeding events compared with men and may derive particular benefit from abbreviated compared with standard DAPT owing to these numerically lower rates of events. Trial Registration ClinicalTrials.gov Identifier: NCT03023020